The Effect of Walking in Kidney Transplant Patients

Not Applicable

• Conditions: Kidney Transplant; Complications; Cardiac Disease
• Interventions: Device: pedometer

• Registration Number: NCT05003193
• Lead Sponsor: Ege University

Brief Summary

Cardiovascular diseases are among the most common causes of death in kidney transplant patients. Physical activity is of great importance in preventing cardiovascular diseases after transplantation. Although regular physical activity is recommended in international guidelines to prevent post-transplant mortality and morbidity in kidney transplant patients, studies have shown that patients do not follow regular physical activity instructions.The aim of our project is to examine the effect of pedometer-assisted physical activity on metabolic parameters after kidney transplantation.

Detailed Description

Patients with kidney transplant surgery will be randomized to the intervention (n: 34) and control groups (n: 34), respectively, according to the transplant surgery date. Intervention and Control groups will be given the same training on the importance of physical activity during discharge training. The pedometer will be given to the intervention group to evaluate the activity level, and it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge. Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days. Patients in the control group will only be advised to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days. Metabolic parameters of the patients in the intervention and control groups will be examined at the end of the 4th and 12th months. These parameters are blood pressure, body mass index, complete blood count (hemoglobin, leukocyte, thrombocyte), blood glucose, sodium, potassium, calcium, liver enzymes, serum creatinine, total and indirect bilirubin, albumin and total cholesterol levels.

Study Timeline

• Study Start: 2020-11-19
• Study First Submitted: 2021-03-30
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Over the age of 18 and under the age of 65,

• Kidney transplantation at the center where the study was conducted between the research dates,
• There is no activity restriction recommendation by the physician,
• Patients who agree to participate in the study.

Exclusion Criteria

• Multiple organ transplantation at the same time,
• Death or graft loss/rejection in the hospital before discharge,
• Patients with physical activity restrictions by the physician,
• Patients who are re-hospitalized within the first 3 months after discharge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Using a pedometer	pedometer	The pedometer will be given to the intervention group to evaluate the activity level and to encourage a walk , it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge. Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Change from Baseline Blood Pressure at 12 months after discharge	mmHg
Hemoglobin	Change from Baseline Hemoglobin at 12 months after discharge	g/dL
Indirect Bilirubin	Change from Baseline Sodium at 12 months after discharge	mg/dL
Alkaline Phosphatase	Change from Baseline Sodium at 12 months after discharge	U/L
Body Mass Index (BMI)	Change from Baseline BMI at 12 months after discharge	BMI is weight in kilograms divided by height in meters squared. Formula: weight (kg) / \[height (m)\]2
Leukocyte	Change from Baseline Leukocyte at 12 months after discharge	10\^3/µL
Sodium	Change from Baseline Sodium at 12 months after discharge	mEq/L
Aspartate Aminotransferase	Change from Baseline Sodium at 12 months after discharge	U/L
glucose in urine	Change from Baseline Sodium at 12 months after discharge	mg/dL
Thrombocyte	Change from Baseline Thrombocyte at 12 months after discharge	10\^3/µL
Blood Glucose	Change from Baseline Blood Glucose at 12 months after discharge	mg/dL
Potassium	Change from Baseline Sodium at 12 months after discharge	mEq/L
Alanine aminotransferase	Change from Baseline Sodium at 12 months after discharge	U/L
Triglyceride	Change from Baseline Sodium at 12 months after discharge	mg/dL
Total Cholesterol	Change from Baseline Sodium at 12 months after discharge	mg/dL
Serum Creatinine	Change from Baseline Sodium at 12 months after discharge	mg/dL
Total Bilirubin	Change from Baseline Sodium at 12 months after discharge	mg/dL
Calcium	Change from Baseline Sodium at 12 months after discharge	mEq/L
High-density lipoprotein (HDL) cholesterol	Change from Baseline Sodium at 12 months after discharge	mg/dL
Low-density lipoprotein (LDL) cholesterol	Change from Baseline Sodium at 12 months after discharge	mg/dL
Albumin	Change from Baseline Sodium at 12 months after discharge	g/dL

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey